The invention relates in a first aspect to a method for the treatment of symptoms related to normal hormonal variations in women during fertile as well as, peri- and post-menopausal age, by the administering of a composition comprising, as active ingredients, a water and/or fat soluble cytosolic extract of pollen, optionally combined with Royal Jelly and Vitamin E.
The invention, in another aspect, relates to the use of a composition comprising, as active ingredients, a water and/or fat soluble extract of pollen optionally combined with Royal Jelly and Vitamin E for the manufacturing of a medicament for the treatment of symptoms relating to normal hormonal variations in women during fertile, as well as peri- and post-menopausal age.
An extract of combined pollen and pistils combined with a pollen grain extract, Royal Jelly and Vitamin E has been sold by Interhealth AB, Kungsangsvagen 27, 561 56 Huskvarna, Sweden, for the treatment of Pre-Menstrual Syndrome (PMS).
Said composition was thought to be active against PMS symptoms in general but the present inventors during research work found out that the composition as disclosed in the application showed an unexpected advantageous effect on some symptoms relating to normal variations in the hormone cycle of women. Other symptoms, such as heart rate and blood pressure, remain unaffected of the remedy.
However, unexpected is an beneficial effect on some symptoms relating to normal hormone variations of women of fertile, as well as peri- and post-menopausal age, obtained by the administering of a composition comprising, as active ingredients a water- and/or fat-soluble cytosolic extract of pollen and/or pistils, optionally in combination with Royal Jelly and Vitamin E.
Said symptoms in the peri- and post-menopausal women are selected from menopausal hot flashes, tendencies of sweating, palpitations, muscle pains, headache, difficulties in passing water, stress incontinence, dysphoria, dry vaginal and mucous membranes, arthralgia, water retention, irritability, and variations in mood.
For women in fertile age the most unexpected and surprising effects were obtained on the symptoms selected from irritability, dysphoria, bloatness, edema, breast tension (mastalgia), weight changes, tension, headache, sleep disturbances, overall wellbeing and interference in social and professional life.
The active composition comprises cytosolic extracts of combined pollen and pistils (PI 82), and a pollen extract (GC FEM) and optionally, as excipients, Royal Jelly and Vitamin LE.
A daily dosage should contain from 60 to 960 mg, preferably 120 mg of PI 82, and from 18 to 288 mg, preferably 36 mg, of GC FEM and from 3 to 48 mg, preferably 6 mg, of Royal Jelly. Vitamin E might be included in an amount of from 5 to 80 mg, preferably 10 mg. The composition can be administered in any suitable form and can, given as a tablet be administered to the woman in need thereof, 1 to 8 times daily.
Preferably, a daily dosage should give from 60 to 480 of PI 82, and from 20 to 140 of GC FEM and from 2 to 30 of Royal Jelly. Vitamin E might be supplied in an amount from 5 to 60 mg/day supplied 1 to 6 times daily.
More preferably, the ingredients are included in the remedy in amounts ranging from 60 to 360 mg of PI 82, 20 to 70 mg of GC REM and 2 to 15 mg of Royal Jelly, and 10 to 40 mg of Vitamin E, supplied 1 to 4 times/day.
Most preferably, the ingredients are included in the remedy in an amount of 120 mg PI 82, 36 of GC FEM, 6 mg of Royal Jelly and 10 mg of Vitamin E, supplied 1 to 4 times/day.
The remedy comprising the active ingredients should be submitted to the women in need thereof during at least one month, preferably at least two months.
Other excipients are included in amounts well known to any one skilled in the art of pharmaceutical sciences.
The cytosolic pollen-pistil extract, PI 82, contains mimics of the antioxidant enzyme super-oxide dismutase (SOD), the cytosolic extract, GC FEM, contains natural bioflavonoides, vitamins, enzymes and trace elements. Royal Jelly is rich in pantothenic acid (also called Vitamin B5), further vitamins and sterols. Royal Jelly is preferably used in lyophilized form. The pollen and pistils used for the natural extracts are selected and harvested primarily from selected members of the grass (Poaceae) family. They have been specially treated to minimize any risk of allergic pollen reactions. The products can be purchased from Natumin Pharma AB, Kungsxc3xa4ngsvxc3xa4gen 27, S-561 51, Huskvarna, Sweden, the Royal Jelly from AB Montoil, Box 24150, S-104 51 Stockholm, Sweden. Vitamin E is preferably used in the form, Dry Vitamin E 50%, Type SD, from F. Hoffmann-La Roche Ltd., CH-4070 Basel, Switzerland. In the preparation dl-alfa-tokoferol is used but other forms might also be valuable.
Disorders relating to normal variation of the sex hormone cycle of women of fertile age are tension, irritability, dysphoria, abdominal distension or bloatness, severe mastalgia (breast tension), headache or migraine, edema, weight changes and sleep disturbances. The overall well being as well as the social and professional life may be influenced.
Over the years at least different treatment options have been suggested to be effective for the treatment of the above-mentioned symptoms. However few have shown a consistent efficacy on irritability, dysphoria, bloatness and edema, tension, breast tension, weight gain, headache and sleep disturbances related to normal variations in the sex hormone cycle of women of fertile age. The pharmacological treatments that have been tried include serotonin re-uptake inhibitors, diuretics, hormonal treatment as well as dietary interventions with e.g. vitamin and mineral supplementation, and natural products. Many of the compounds used for the treatment are limited due to adverse effects. Therefore it is a great need for safe compounds with a consistent efficacy.